Home NDC 51662-1606 0.25% BUPIVACAINE HCl
Product NDC 51662-1606
11-digit product format 516621606
Labeler code 51662
Product ID 51662-1606_1b5824c7-c46a-48c6-e063-6394a90a22ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name 0.25% BUPIVACAINE HCl
Dosage form INJECTION, SOLUTION
Route INFILTRATION; PERINEURAL
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA070590
Marketing category ANDA
Marketing start 2022-08-01
Substance BUPIVACAINE HYDROCHLORIDE
Active strength 2.5 mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070590-001 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070590-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070590-001 BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE / INJECTION AP 1987-02-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base 0.25% BUPIVACAINE HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7TQO7W3VT8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012396 Internal RxNorm lookup 1012404 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51662-1606-2 0.25% BUPIVACAINE HCl 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 11 51662-1606-2 0.25% BUPIVACAINE HCl 1 in 1 POUCH INJECTION, SOLUTION 1 11 51662-1606-3 0.25% BUPIVACAINE HCl 25 in 1 CASE INJECTION, SOLUTION 25 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1606 BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION 0.25% BUPIVACAINE HCL INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 11 Current NDC, Legacy NDC, 3 package rows 20240622_950d82b6-76a1-0c08-e053-2a95a90a3a92.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Hospira, Inc. 02a845c3-4521-4926-e397-25ab536e7cf6 2026-03-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070590 application number: ANDA070590 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Henry Schein, Inc 3c0f567f-b7f8-4ee8-bfb2-61cd82550498 2025-10-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070590 application number: ANDA070590 BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 950d82b6-76a1-0c08-e053-2a95a90a3a92 2024-06-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 070590 application number: ANDA070590 ndc (product): 51662-1606 Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE Medical Purchasing Solutions, LLC ada6a9bf-f7cb-035a-e053-2a95a90a6a3d 2023-05-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 070590 application number: ANDA070590
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51662-1606-2 51662160602 50 mL in 1 VIAL, MULTI-DOSE 50 ml Historical 51662-1606-3 51662160603 25 POUCH in 1 CASE (51662-1606-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1606-2) / 50 mL in 1 VIAL, MULTI-DOSE 25 pouch 2022-08-01 0000-00-00 No No Current